AI illustration · not actual product photoDetails from the source.
Source-listed Dihexa (SKU DI10): 10mg*10vials. PriceList(1).pdf lists 56 per 10 vials but does not specify currency; the website displays $56 per 10 vials in USD per owner instruction. The source row does not establish the supplier-specific item's identity, lot quality, or approval.
- Catalogue code
- DI10
- Source specification
- 10mg*10vials
- Source document
- PriceList(1).pdf, page 4
- Photograph
- AI-generated illustration only — not an actual product photo or verified molecular depiction; owner-approved product photo still pending.
Product information is presented from supplied source materials. Inclusion on this website does not state that a product is an approved medicine or authorize human use. This is educational content, not medical advice.
Compound-level research and safety context.
Evidence below concerns the research family associated with this listing. For blends, findings about individual components do not establish evidence for the combination. This does not verify the supplier-specific vial or lot. Reviewed 2026-10-30.
What it is
Synthetic modified angiotensin-IV-derived compound, described as a modified dipeptide/peptidomimetic rather than a conventional unmodified peptide. Investigational/preclinical evidence exists, but Dihexa itself has no established human medical use. Do not label the exact catalogue vial compounded or research-only: the supplied documentation does not establish either status.
Biological mechanism
A proposed HGF/MET-modulating mechanism and effects on synapse formation were reported in a 2014 paper that was formally retracted in 2025; those claims are unconfirmed. A separate mouse study reported PI3K/AKT-associated changes, but this does not establish mechanism in humans.
Research focus
Preclinical learning, memory, synapse-related measures, and Alzheimer’s-disease-like cognitive impairment models. The evidence is primarily from laboratory and animal research.
Potential applications in the evidence
Cognition and memory in preclinical models, including Alzheimer’s-disease-like models, are investigated areas only. Evidence does not establish clinical benefit or an indicated application in people.
Human evidence
No published human clinical study of Dihexa itself was identified in the reviewed sources. Fosgonimeton (ATH-1017), a distinct investigational prodrug designed to yield a related active HGF/MET-modulating moiety, has been studied in people. Its short Phase I trial included 11 participants with Alzheimer’s disease among multiple cohorts. In the 554-participant Phase 2/3 LIFT-AD trial, fosgonimeton failed to meet primary and secondary clinical endpoints. These results are not direct studies of this catalogue vial and do not establish its safety or effectiveness.
Known and potential effects
No reliable human adverse-effect profile for Dihexa itself is established. FDA reports no identified human exposure data for drug products containing Dihexa acetate and says important safety information is lacking. In the distinct fosgonimeton LIFT-AD study, adverse-event discontinuations were more frequent in the fosgonimeton group than placebo, mostly due to injection-site reactions; this cannot be attributed to this Dihexa listing.
Safety and contraindications
Human safety, contraindications, interactions, and route-specific risks for Dihexa itself are not established. The absence of reported effects is not evidence of safety. The catalogue provides no manufacturer, chemical form, formulation, route, purity, sterility, contaminant, or quality-control documentation for the exact vial, so identity and product-specific safety cannot be verified.
U.S. FDA / regulatory status
No FDA approval for Dihexa as a human drug or for this supplier-specific vial was identified in the sources reviewed. FDA lists Dihexa acetate among bulk-substance nominations withdrawn by nominators and notes the human-safety information gap. FDA also lists Dihexa acetate for discussion at a future advisory committee meeting concerning possible inclusion on the 503A bulks list; a planned discussion is not an approval or inclusion decision. The catalogue does not establish that the exact item is compounded, research-only, or authorized in any jurisdiction. Approval of any related or different formulation would not transfer to this vial.
Evidence limitations
Evidence is limited by the absence of direct human Dihexa studies, reliance on preclinical models, formal retraction of the most-cited HGF/MET mechanism paper, and absent product-specific identity and quality records. Human findings for fosgonimeton cannot be treated as proof about Dihexa itself or this supplier-specific product. Catalogue label, specification and price are from supplied documents only; the currency is not stated.
Supporting sources
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks U.S. Food and Drug Administration · Regulatory safety communication. Supports: FDA’s withdrawn Dihexa acetate nomination record, lack of identified human exposure data for drug products containing Dihexa acetate, and safety-information gap.
- Meeting of the Pharmacy Compounding Advisory Committee U.S. Food and Drug Administration · Official advisory committee information. Supports: FDA lists Dihexa acetate for future committee discussion on potential 503A bulks-list inclusion; the page describes advisory recommendations as nonbinding.
- Retraction notice to The Procognitive and Synaptogenic Effects of Angiotensin IV-Derived Peptides PubMed / Journal of Pharmacology and Experimental Therapeutics · Formal retraction notice indexed by NLM. Supports: Formal retraction in 2025 of the widely cited 2014 paper supporting proposed Dihexa HGF/MET, synaptogenic, and procognitive mechanism claims.
- AngIV-Analog Dihexa Rescues Cognitive Impairment and Recovers Memory in the APP/PS1 Mouse via the PI3K/AKT Signaling Pathway Brain Sciences / PubMed Central · Preclinical animal study. Supports: Animal-only findings on mouse cognition, tissue and PI3K/AKT-associated measures; supports the distinction between preclinical results and human evidence.
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Fosgonimeton in Healthy Volunteers and Subjects with Alzheimer's Disease PubMed / Journal of Alzheimer's Disease · Phase I clinical trial publication. Supports: Human Phase I data for fosgonimeton, a distinct prodrug, including study size/cohorts and why the findings are not direct evidence for the catalogue vial.
- Fosgonimeton in mild-to-moderate Alzheimer's disease Journal of Alzheimer's Disease Reports / PubMed Central · Peer-reviewed Phase 2/3 clinical trial report. Supports: LIFT-AD trial size, failure to meet primary and secondary endpoints, and reported adverse-event discontinuations for fosgonimeton.